Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 4/17/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 4/17/2026 of Group I. Claim(s) 147-157 and 167-171 is acknowledged.
Applicant has elected without traverse in the Reply filed on 4/17/2026 the following species:
A. the first click label comprises a first reactive group that is configured to couple to the first clack reagent, wherein said first clack reagent comprises: (i) a second reactive group that is coupled to or configured to couple to a first reporter moiety configured to emit at least a first signal or signal change (claim 147)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 147-157 and 167-171 are pending.
Claims 147-157 and 167-171 are under examination in this Office Action.
Claim Rejections - 35 USC § 112-1st paragraph (Written Description)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of 35 U.S.C. 112 (pre-AIA ):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 147-157 and 167-171 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 148-157 and 167-171 depend directly or indirectly from claim 147.
The specification discloses chemicals, such as the combination of the peptide, the click label and the clack reagent described in Example 4 which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 147-157 and 167-171 is(are) directed to encompass any peptide, click label, and clack reagent, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these combination of analogs, meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of specific combinations of peptide, click label, and clack reagent. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 147-157 and 167-171 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swaminathan et al. (2018) Nature Biotechnology volume 36 pages 1076 to 1082 cited in the 8/19/2024 IDS (hereinafter known as "Swaminathan").
With regards to claims 147-157 and 167-171, Swaminathan teaches:
a) as in claims 147-157 and 167-171, a system comprising a peptide, a first click label, and a first clack reagent, wherein said peptide is immobilized to at least one support; and wherein said peptide comprises a first amino acid residue configured to couple to said first click label, wherein said first click label comprises a first reactive group that is configured to couple to said first clack reagent, wherein said first clack reagent comprises: (i) a second reactive group that is coupled to or configured to couple to a first reporter moiety configured to emit at least a first signal or signal change; wherein a C-terminus of said peptide is coupled to said at least one support; wherein said C-terminus is modified with a compound comprising an alkyne; wherein an N-terminus of said peptide is coupled to a first support of said at least one support, wherein said first support is a bead; wherein said first amino acid residue is selected from the group consisting of a lysine residue, a cysteine residue, a glutamic acid residue, an aspartic acid residue, a tyrosine residue, an arginine residue, a histidine residue, a threonine residue, a serine residue, a proline residue, an asparagine residue, a glutamine residue, and a tryptophan residue; wherein said first reactive group is selected from the group consisting of an azide, an alkyne, an alkene, an aldehyde, a ketone, a tetrazine, a thiol, a dithiol, a cyclooctene, and norbornene; wherein said second reactive group is selected from the group consisting of an alkyne, an azide, a thiol, a dithiol, a cyclooctene, an alkene, an aldehyde, a ketone, a tetrazine, and norbornene; wherein: (a) said first reactive group is the same as said third reactive group; wherein (a) said first reactive group is different from said third reactive group; wherein: (a) said first reporter moiety is the same as said second reporter moiety; wherein (a) said first reporter moiety is different from said second reporter moiety; further comprising a second click label and a second clack reagent, wherein said peptide comprises a second amino acid residue configured to couple to said second click label, said second click label comprises a third reactive group that is configured to couple to said second clack reagent, and wherein said second clack reagent comprises: (i) a fourth reactive group that is coupled to or configured to couple to a second reporter moiety configured to emit at least a second signal or signal change; further comprising a third click label and a third clack reagent, wherein said peptide comprises a third amino acid residue configured to couple to said third click label, and wherein said third click label comprises a fifth reactive group that is configured to couple to said third clack reagent, wherein said third clack reagent comprises: (i) a sixth reactive group that is coupled to or configured to couple to a third reporter moiety configured to emit at least a third signal or signal change; wherein said second amino acid residue and said third amino acid residue are each, independently, selected from the group consisting of a lysine residue, a cysteine residue, a glutamic acid residue, an aspartic acid residue, a tyrosine residue, an arginine residue, a histidine residue, a threonine residue, a serine residue, a praline residue, an asparagine residue, a glutamine residue, and a tryptophan residue; wherein said third reactive group and said fifth reactive group are each, independently, selected from the group consisting of an azide, an alkyne, an alkene, an aldehyde, a ketone, a tetrazine, a thiol, a dithiol, a cyclooctene, and norbomene; wherein said fourth reactive group and said sixth reactive group are each, independently, selected from the group consisting of an alkyne, an azide, a thiol, a dithiol, a cyclooctene, an alkene, an aldehyde, a ketone, a tetrazine, and norbomene (see entire document especially Abstract, supplementary figure 3 and pages 1077 and 1083).
Thus, Swaminathan anticipates the present claims.
Conclusion
No claim is allowed.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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